CLINICAL TRIALS PROFILE FOR SAMSCA

All Clinical Trials for SAMSCA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01199198 ↗	Tolvaptan in Hyponatremic Cancer Patients	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 4	2011-05-01	The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.
NCT01199198 ↗	Tolvaptan in Hyponatremic Cancer Patients	Completed	M.D. Anderson Cancer Center	Phase 4	2011-05-01	The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.
NCT01227512 ↗	Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia	Terminated	Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 3	2010-10-01	The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.
NCT01228682 ↗	Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice	Unknown status	Otsuka Frankfurt Research Institute GmbH		2010-10-01	A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice. A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.
NCT01261481 ↗	Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact	Completed	Otsuka America Pharmaceutical	Phase 1	2011-01-01	The purpose of the study is to compare the relative bioavailability and pharmacokinetics of tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in healthy male and female subjects. This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28 healthy adults. Subjects will be randomized to one of the two treatment sequences; either tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected following each tolvaptan administration and safety assessments will be performed. The relative bioavailability of tolvaptan administered via nasogastric tube will be compared to tolvaptan tablets swallowed intact.
NCT01261481 ↗	Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact	Completed	University of North Carolina, Chapel Hill	Phase 1	2011-01-01	The purpose of the study is to compare the relative bioavailability and pharmacokinetics of tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in healthy male and female subjects. This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28 healthy adults. Subjects will be randomized to one of the two treatment sequences; either tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected following each tolvaptan administration and safety assessments will be performed. The relative bioavailability of tolvaptan administered via nasogastric tube will be compared to tolvaptan tablets swallowed intact.
NCT01346072 ↗	Pilot Study of Using Copeptin to Predict Response to Tolvaptan	Completed	Otsuka America Pharmaceutical	Phase 4	2011-04-01	This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours. For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.

Clinical Trial Conditions for SAMSCA

Condition Name

Condition Name for SAMSCA
Intervention	Trials
Hyponatremia	10
Heart Failure	5
Ascites	4
Hepatic Cirrhosis	3

Condition MeSH

Condition MeSH for SAMSCA
Intervention	Trials
Hyponatremia	13
Heart Failure	12
Ascites	5
Fibrosis	4

Clinical Trial Locations for SAMSCA

Trials by Country

Trials by Country for SAMSCA
Location	Trials
United States	70
Germany	8
China	5
Denmark	5
Italy	4

Trials by US State

Trials by US State for SAMSCA
Location	Trials
North Carolina	5
Pennsylvania	5
Georgia	5
Colorado	4
Texas	4

Clinical Trial Progress for SAMSCA

Clinical Trial Phase

Clinical Trial Phase for SAMSCA
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	10
Phase 2	4

Clinical Trial Status

Clinical Trial Status for SAMSCA
Clinical Trial Phase	Trials
Completed	21
Terminated	6
Unknown status	5

Clinical Trial Sponsors for SAMSCA

Sponsor Name

Sponsor Name for SAMSCA
Sponsor	Trials
Otsuka Pharmaceutical Development & Commercialization, Inc.	7
Otsuka America Pharmaceutical	6
Otsuka Beijing Research Institute	4

Sponsor Type

Sponsor Type for SAMSCA
Sponsor	Trials
Other	46
Industry	24
U.S. Fed	1